Welldoc-posted 8 months ago
$120,000 - $175,000/Yr
Full-time • Mid Level
Columbia, MD
Ambulatory Health Care Services

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A key member of the QA organization of a growing medical device company developing and manufacturing software as medical devices. The position is located in Columbia, Maryland and will interface with the R&D engineering team located in Bangalore, India. Champion Quality Assurance activities related to product development, new product introduction and provide leadership in fostering a culture of quality. Provide inputs to software R&D designs, develop test strategies for software systems, improve quality processes as they apply to software systems. Proactively provides guidance to the functional teams to ensure Quality System compliance. Partner with Product Development to review requirements to ensure appropriate level of rigor to software validation and verification as well as address risk management, quality planning, design input, design output, design verification/validation, and design transfer. Partner with the Software QA and Development team in order to execute software test and quality assurance including software verification strategies, test scripts, and traceability to requirements. Provide quality support for the change control process including quality approval of design changes/enhancements, bug fixes, and infrastructure changes. Actively identifies, drives, and participates in project efforts related to compliance. Oversees the scheduling and auditing of the Quality System controls, including external vendor assessments. Evaluates regulatory landscapes both nationally and internationally to contribute to business strategy.

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